NCT04064580

Brief Summary

Obstructive respiratory diseases such as asthma or COPD are a common reason for emergency room visits. Currently, nasal gill capnography and oxygen saturation measurement (SpO2) are the only two non-invasive means of continuously monitoring a respiratory pathology. To date, Respiratory Functional Explorations (CFE) and more particularly spirometry, are considered as the reference examinations for the diagnosis or monitoring of asthma or COPD. However, physical and physical constraints make their use almost impossible in the context of the emergency with patients presenting to emergencies in respiratory distress, often require oxygen therapy or even non-invasive ventilation. Only pulmonary auscultation can make the diagnosis of acute decompensation of obstructive pathology. This technique is qualitative and imprecise, sometimes leading to a diagnostic uncertainty resulting in delay in taking charge and inappropriate therapy. Studies have shown a change in the capnography curve in obstructive airway disorder and a strong correlation between some capnography parameters and spirometry parameters such as the Tiffeneau ratio (FEV1 / FVC), suggesting capnography as a simple and effective technique for the diagnosis of obstructive syndrome of patients in emergencies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 15, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

July 11, 2019

Last Update Submit

October 14, 2019

Conditions

Keywords

capnography

Outcome Measures

Primary Outcomes (1)

  • Spirometry measurement

    Tiffenau Report Compendium (FEV1 / FVC) and FEV1 for spirometry (gold standard defining presence of obstructive disorder). Collection of the capnography curves of each patient allowing in a second time to perform an analysis of the curve by different methods.

    1 day

Interventions

performing a capnography examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major patient requiring spirometry breathing functional exploration

You may qualify if:

  • Major patient male or female
  • Patient with respiratory disease with and without obstructive syndrome or patient without respiratory pathology
  • Patient requiring spirometry breathing functional exploration
  • Subject affiliated to a social health insurance scheme
  • Subject able to understand the objectives and the risks related to the research and to give its non opposition

You may not qualify if:

  • Pregnant and lactating woman
  • Patient not affiliated to a social protection scheme
  • Impossibility of giving the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...)
  • Subject under the protection of justice Subject under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2019

First Posted

August 22, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2019

Study Completion

July 1, 2021

Last Updated

October 15, 2019

Record last verified: 2019-07

Locations